Mechanisms of Skin Repair by Topical Estrogen | RxWiki

Mechanisms of Skin Repair by Topical Estrogen

Overview[ - collapse ][ - ]

Purpose	The purpose of this study is to investigate the way by which estrogen improves the appearance of sun damaged human skin. Accumulating evidence suggests that estrogen, taken by post menopausal women, may cause skin to look younger as a consequence of reduced wrinkles. Collagen is the most abundant protein in human skin and gives skin its strength and shape. Recent data indicate that short-term topical estrogen (17-beta estradiol) treatment increases collagen production in sun damaged skin. This study will compare the molecular and microscopic effects from topical 17-beta estradiol (E2) when applied to the skin for a short-term duration. It is anticipated that the new knowledge from this study will enable development of new ways to improve the function of aged skin.
Condition	Skin Wrinkling
Intervention	Drug: Topical 17-beta estradiol in ethanol/propylene glycol (ETOH/PG)
Phase	N/A
Sponsor	University of Michigan
Responsible Party	University of Michigan
ClinicalTrials.gov Identifier	NCT00113100
First Received	June 3, 2005
Last Updated	August 6, 2008
Last verified	August 2008

Tracking Information[ + expand ][ + ]

First Received Date	June 3, 2005
Last Updated Date	August 6, 2008
Start Date	August 2004
Estimated Primary Completion Date	June 2007
Current Primary Outcome Measures	Endpoints will include, protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue
Current Secondary Outcome Measures	Not Provided

Descriptive Information[ + expand ][ + ]

Brief Title	Mechanisms of Skin Repair by Topical Estrogen
Official Title	Mechanisms of Skin Repair by Topical Estrogen in Vivo
Brief Summary	The purpose of this study is to investigate the way by which estrogen improves the appearance of sun damaged human skin. Accumulating evidence suggests that estrogen, taken by post menopausal women, may cause skin to look younger as a consequence of reduced wrinkles. Collagen is the most abundant protein in human skin and gives skin its strength and shape. Recent data indicate that short-term topical estrogen (17-beta estradiol) treatment increases collagen production in sun damaged skin. This study will compare the molecular and microscopic effects from topical 17-beta estradiol (E2) when applied to the skin for a short-term duration. It is anticipated that the new knowledge from this study will enable development of new ways to improve the function of aged skin.
Detailed Description	The objectives of the study are to determine if topically-applied 17-beta estradiol (E2), alone or in combination with clobetasol, will produce histological and molecular effects distinguishable from vehicle in human skin. Specifically, the study will focus on regulation of collagen, elastin, and hyaluronic acid production and degradation in human skin, by steroid hormone receptors that are activated by estrogen or clobetasol. The sites to be treated will be buttock, hip, forearm, or facial skin. Subjects will receive between one to twelve vehicle (matching solution without any active ingredients), estrogen, and/or clobetasol topical applications. Skin biopsies of treated areas will be obtained at baseline and at subsequent timepoints. The study will last up to two weeks. Endpoints will include protein and mRNA levels of collagen, elastin, hyaluronic acid, and other components of skin connective tissue. In addition, we will perform cDNA microanalysis to determine estrogen/clobetasol target genes in human skin. The results from our studies will provide new knowledge regarding the molecular basis of skin aging. This new knowledge will enable development of new ways to improve the function of aged skin.
Study Type	Interventional
Study Phase	N/A
Study Design	Allocation: Non-Randomized, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
Condition	Skin Wrinkling
Intervention	Drug: Topical 17-beta estradiol in ethanol/propylene glycol (ETOH/PG)
Study Arm (s)	Not Provided

Recruitment Information[ + expand ][ + ]

Recruitment Status	Completed
Estimated Enrollment	152
Estimated Completion Date	June 2007
Estimated Primary Completion Date	June 2007
Eligibility Criteria	Inclusion Criteria: - Healthy post-menopausal (without spontaneous menstrual bleeding for at least 1 year) women, and men, at least 50 years of age and any racial/ethnic type. - Subjects must understand and sign the informed consent prior to participation. - Subjects must be in generally good health. - Subjects must be available for follow-up visits to comply with the requirements of the protocol. - Not on estrogen replacement therapy within the past 3 months. - No nonsteroidal anti-inflammatory drugs two weeks prior to study entry. - No topical steroids two weeks prior to study entry. - You must live within a reasonable driving distance of Ann Arbor, Michigan, and/or be able to attend all of the scheduled appointments during the study. Exclusion Criteria: - History of keloid formation or hypertrophic scarring. - History of reaction to lidocaine anesthetic. - Subjects with significant medical history or concurrent condition which the investigator(s) feel is not safe for study participation and which would impair evaluation of test sites.
Gender	Both
Ages	50 Years
Accepts Healthy Volunteers	Accepts Healthy Volunteers
Contacts	Not Provided
Location Countries	United States

Administrative Information[ + expand ][ + ]

NCT Number	NCT00113100
Other Study ID Numbers	Derm 530
Has Data Monitoring Committee	Not Provided
Information Provided By	University of Michigan
Study Sponsor	University of Michigan
Collaborators	Not Provided
Investigators	Study Chair: John J Voorhees, MD University of Michigan
Verification Date	August 2008

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